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NCT Number: NCT01234506

Oxidative Stress and Nutritional Supplementation Intervention Study

A major means whereby oxidative stress promotes aging-related disease is by activating inflammatory pathways. Decreasing oxidative stress and inflammation should ameliorate many of the problems associated with aging, including vascular dementia, Alzheimer's disease, osteoporosis, muscle wasting, insulin resistance, type 2 diabetes, and metabolic syndrome. Animal and human studies have demonstrated that consumption of vitamin D and phase 2 protein inducers decrease oxidative stress and associated inflammation. The flax lignan secoisolariciresinol diglucoside (SDG) is metabolized to enterolactone, a potent phase 2 protein inducer. Animal and human studies have shown that consumption of flax seed or its component SDG decreases hypertension, serum cholesterol, atherosclerosis, the growth of experimentally-induced cancers as well as metastases of human breast tumours implanted into nude mice, and delays the development of type 2 diabetes. Vitamin D plays a role in modulating inflammation, enhancing immunity (while suppressing autoimmune injury) and exerting control over cell differentiation. Adequate levels of vitamin D also appear to promote better glycemic control. The investigators predict that consumption of SDG in persons with adequate vitamin D status will decrease oxidative stress and associated inflammation. If this hypothesis is upheld, this research has the potential to greatly decrease healthcare costs while allowing healthier aging.

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Key information

Conditions

Oxidative Stress Aging Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Depression Inflammation Mental Disorders Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Neuromuscular Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Saskatoon Health Region

Saskatoon, Saskatchewan, S7K 5T6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults residing in a long term care facility
  • resident for a minimum of four weeks prior to entry
  • able to comply with study protocol
  • able to follow simple instructions
  • able to give informed consent or has a legally acceptable representative who is able to provide consent

Exclusion criteria

  • Age below 60 or above 80 years.
  • Individuals at risk of hypotension or with symptomatic hypotension.
  • Fasting hypoglycemia.
  • Unstable diabetes
  • Diabetics taking insulin
  • Current cancer or diagnosed with cancer in the past 2 years.
  • Women with an immediate family history or personal history of breast cancer or ovarian cancer
  • Significant liver disorder
  • Significant gastrointestinal disorder including inflammatory bowel disease but not constipation
  • Significant kidney disorder
  • Unstable or severe cardiac disease, recent MI or stroke either in past 6 months or significantly (i.e., severely) affecting physical mobility.
  • Unstable other medical disease including, but not limited to, pulmonary disorder, epilepsy and genitourinary disorder.
  • Migraine with aura within the last year (as this is a risk factor for stroke).
  • Current diagnosis of a bleeding condition, or at risk of bleeding.
  • Significant immunocompromise.
  • Other unstable conditions.
  • Current use of hormone replacement therapy except thyroid medication
  • Current use of warfarin, clopidogrel, ticlopidine, dipyridamole or their analogues.
  • Intolerances or allergies to flax or vitamin D.
  • Estimated probability of longevity of less than one year based on medical opinion

Treatment and study plan

secoisolariciresinol diglucoside

Dietary Supplement

SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks

Other names: Beneflax Flax Lignan Extract Archer Daniels Midland,#080001., Natural Factors Whey Factors whey protein (unflavored)., Vitamin D NPN 80003663 WN Pharmaceuticals

Primary outcomes

  1. Safety of consumption of 300 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y)

    Time frame: 24 weeks

    Adverse event occurrences will be compared descriptively between the SDG and placebo groups. Safety will be assessed at 0, 6, 12, 18 and 24 weeks; as part of the blood collection (urea, creatinine, total bilirubin, platelets, hematocrit, haemoglobin, mean corpuscular haemoglobin, mean corpuscular volume, white blood cell count, total protein including albumin and prealbumin, total calcium, electrolytes, glucose, liver enzymes (AST, ALT, ALP), total protein, albumin, lipids, HbA1c (for diabetic participants). Blood pressure measurements will be performed every two weeks

  2. Effect of SDG on oxidative stress and inflammation

    Time frame: 24 weeks

    SDG and placebo groups will be compared at 0, 12 and 24 weeks for changes in oxidative stress measurements (plasma malondialdehyde), pro-inflammatory markers (IL-6, IL-1α, IL-1β, 8-isoprostane, TNF-α, C-reactive protein).

Secondary outcomes

  1. Effect of SDG on quality of life

    Time frame: 24 weeks

    SDG and placebo groups will be compared at 0, 12 and 24 weeks for changes in cognitive function, pain, and physical function including falls, as well as performance of activities of daily living.

  2. Effect of SDG supplement on blood levels of flax lignan metabolites

    Time frame: 24 weeks

    To further understand the pharmacology of SDG, we will analyze plasma levels of the SDG metabolites secoisolariciresinol, enterolactone and enterodiol in those subjects given flax lignan supplement. Levels will be determined 0, 12 and 24 weeks.

  3. To measure effects of SDG on bone resorption

    Time frame: 24 weeks

    SDG and placebo groups will be compared at 0 and 24 weeks for changes in bone resorption as assessed by measurement of cross-linked N-telopeptides type I collagen serum levels.

  4. Effect of SDG on blood lipids

    Time frame: 24 weeks

    SDG and placebo groups will be compared at 0, 12 and 24 weeks for changes in nonfasting levels of cholesterol, LDL, HDL, and triglycerides.

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Saskatchewan Health Research Foundation

Registry information

Official study title

Community Alliance for Quality of Life in Long Term Care: Oxidative Stress and Nutritional Supplementation Intervention Study

Acronym: Oxi-Stress

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 4, 2010
Registry last updated
Oct 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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